LINOLA

LINOLA fett N oil bath

Important notes (mandatory information)

Linola Fett N Ölbad. Areas of application: for the supportive treatment of dry or scaly dermatoses, such as psoriasis and neurodermatitis (endogenous eczema).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Linola Fett N Ölbad

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS LINOLA FETT N ÖLBAD AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING LINOLA FETT N ÖLBAD?
3. HOW TO USE LINOLA FETT N ÖLBAD?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LINOLA FETT N ÖLBAD?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LINOLA FETT N ÖLBAD AND WHAT IS IT USED FOR?

Linola Fett N Ölbad is a greasy, liquid bath additive for use on the skin for full, partial and shower baths. Linola Fett N Ölbad is used for the supportive treatment of dry or scaly dermatoses, such as psoriasis and neurodermatitis (endogenous eczema).

2. WHAT SHOULD YOU CONSIDER BEFORE USING LINOLA FETT N ÖLBAD?

Linola Fett N Ölbad must not be used:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine listed in section 6.
• in case of feverish illnesses, tuberculosis, severe heart and circulatory disorders and high blood pressure. In these cases, full baths, including those with Linola Fett N Ölbad, should not be taken.

Warnings and precautions

Please talk to your doctor or pharmacist before using Linola Fett N Ölbad. Linola Fett N Ölbad should not get into the eyes, as this can cause burning. In case of accidental contact of the eyes with Linola Fett N Ölbad, they should be rinsed thoroughly with water. After using Linola Fett N Ölbad, an oil film remains on the skin and the surface of the bath or shower tray. This increases the risk of slipping. If Linola Fett N Ölbad and latex products (e.g. condoms, diaphragms) are used at the same time, the contained paraffin may reduce the functionality and thus impair the safety of these products.

Use of Linola Fett N Ölbad together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. The additional use of soaps or so-called syndets (synthetic detergents) cancels out the effect of Linola Fett N Ölbad.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Linola Fett N Ölbad can be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

3. HOW TO USE LINOLA FETT N ÖLBAD?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Linola Fett N Ölbad is a liquid bath additive for use on the skin. It is used for a total of 4 weeks as a full, partial or shower bath, depending on the type and extent of the skin disease. Take baths at intervals of 2 - 3 days, depending on the type and extent of the skin disease, and add the following amounts of Linola Fett N Ölbad:

• Full bath (in the bathtub): 30 – 40 ml
• Partial bath (in the sink or in a bowl): 2 ml
• Shower bath (spread Linola Fett N Ölbad on the moistened body and then take a short shower): 20 ml

The water temperature when bathing or showering should not exceed 36°C, as the re-fattening effect decreases at higher temperatures. If there is also itching, the temperature should be 32°C or as low as is still comfortable for you. The bathing time should not exceed 20 minutes. After bathing or showering, you should only dab the skin lightly with a towel, as vigorous drying and rubbing reduces the effect.

Use in children and adolescents

The same dosage recommendations apply to children and adolescents as to adults. For infants and toddlers, a duration of application of only a few minutes is usually sufficient.

If you have used more Linola Fett N Ölbad than you should

No side effects are to be expected if more Linola Fett N Ölbad is used.

If you forget to use Linola Fett N Ölbad

Do not use twice the amount if you have forgotten the previous application. Continue treatment with the usual amount at the next application.

If you stop using Linola Fett N Ölbad

Discuss the further procedure with your doctor, as otherwise the success of the treatment may be jeopardised.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (1 to 10 out of 100 treated patients)

Redness, burning, itching.

Uncommon (1 to 10 out of 1,000 treated patients)

Skin reactions in the form of contact eczema or contact dermatitis, hives, small blisters.

Rare (1 to 10 out of 10,000 treated patients)

Allergic reactions, hair follicle inflammation (folliculitis).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LINOLA FETT N ÖLBAD?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Shelf life after opening: 1 year. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Linola Fett N Ölbad contains

The active ingredients are: 100 g bath additive contains 48 g thick liquid paraffin, 26.4 g hexadecyl(2-ethylhexanoate), 13.2 g octadecyl(2-ethylhexanoate), 4.4 g isopropyl myristate (Ph. Eur.), 6 g alpha-dodecyl-omega-hydroxypoly(oxyethylene)-2, 1 g alpha-(dodecyl, tetradecyl)-omega-hydroxypoly(oxyethylene)-4,5-poly(oxypropylene)-5. The other ingredient is: Savanna fragrance.

What Linola Fett N Ölbad looks like and contents of the pack

Linola Fett N Ölbad is a clear, colourless, liquid bath additive in bottles with polyethylene (HDPE) closures or polyethylene film bags. The pack sizes are: 30 ml (1 bottle of 30 ml or 3 bags of 10 ml), 100 ml (1 bottle of 100 ml or 10 bags of 10 ml), 200 ml (1 bottle of 200 ml or 20 bags of 10 ml), 400 ml (1 bottle of 400 ml or 40 bags of 10 ml), 800 ml (1 bottle of 800 ml). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. August Wolff GmbH & Co. KG
Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Tel.: 0521 8808-05
Fax: 0521 8808-334
E-mail: info@wolff-arzneimittel.de

This package leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 10/2019
Areas of application: for the supportive treatment of dry or scaly dermatoses, such as psoriasis and neurodermatitis (endogenous eczema).